Related Experiment Video
Updated: May 24, 2026

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells
Published on: November 12, 2019
Summary of the US FDA approval of belatacept
P Archdeacon1, C Dixon, O Belen
1Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Abstract:
Elements of the Food and Drug Administration (FDA) review of the clinical data that supported the approval of the Biologics License Application (BLA) for belatacept for prophylaxis of organ rejection in adult patients receiving a kidney transplant are summarized. The article is not intended as a comprehensive summary of the entire belatacept data submission. Rather, the discussion is meant to illustrate aspects of the FDA's process for evaluating efficacy and safety, using belatacept as an example.
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
FDA Approved Drugs: Changes to Approved Drugs
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Bioequivalence studies: Biowaivers

![Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F62334.jpg&w=3840&q=50)